Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634136
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2020-11-04
Brief Title:
Full-spectrum Medical Cannabis for Treatment of Spasticity in Patients With Severe Forms of Cerebral Palsy
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
Full-spectrum Medical Canabis Product HemPhar With a CBDTHC Ratio of 101 for Treatment of Spasticity in Children and Young Adults With Severe Forms of Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HemPhar
Brief Summary:
The proposed study is a double-blind placebo-controlled cross over study on 60 children aged 5 to 25 years with severe spasticity related to cerebral palsy CP level IV and V with full-spectrum medical cannabis product of CBDTHC ratio 101
Detailed Description:
Test components
A Active Full-spectrum medical cannabis with ratio of CBDTHC 101 HemPhar
B Placebo both of the same producer
Study Steps
1 Informed consent should be signed by parentscaregivers
2 Weight of the participant should be determined and an IV line inserted The following lab tests should be performed CBC and differential counts blood electrolytes magnesium calcium phosphorus urea creatinine liver enzymes AST ALT gGT
3 ECG performed and analyzed
4 A trained physiotherapist will perform the following motor assessments spasticity level according to modified Ashworth scale Bohannon functionactivity assessment with the use of Gross Motor Function Measure scale GMFM-88 and assessment of muscle power with dynamometer
5 Randomization of patients into one of the two arms of the study
6 Active substance or placebo are introduced thereafter as an oral oily solution for oral application in a starting dose of 008 mgkg body weight BWtday divided in 2 doses the dose is according to the THC content The dose is gradually increased every 3 days for 008 mg THC kg BWtday until the maximum dose of 1 mg THCkg BWtday is reached or else until adverse effects are noted It is expected that the average dose will be 033 mgkg BWt per day
7 The parentscaregivers are given questionnairesscales and also given oral instructions on how to fulfil them Edmonton scale Borg scale and Global Impression of Change - GIC and the paper to take down notes on possible sideadverse effects while taking the preparation either active substance or placebo
8 After 6 weeks of taking the substance or at the premature end of the study again the lab tests will be performed as well as the motor assessment by the physiotherapist as above at inclusion
9 In patients who have been receiving placebo for the first 6 weeks the active substance is given for the next 6 weeks as described above under 6 The patients who have been receiving the active substance for the first 6 weeks will continue to do so for the next 6 weeks
10 Additional blood samples are taken at 6 weeks in both groups for analysis of levels of cannabidiol CBD as well as delta-9-tetrahydrocannbinol THC - around 4 ml of blood for determination of both levels at times after ingestion 0 1 2 4 8 and 24 hours
11 At the end of the study after 12 weeks again repeat
1 CBC and differential counts blood electrolytes magnesium calcium phosphorus urea creatinine liver enzymes AST ALT gGT
2 ECG
3 Motor assessments by a physiotherapist AshworthBohannon GMFM 88 dynamometer
4 Pharmacokinetics 4 ml of blood for determination of phamacokinetics after ingestion of the last dose as in point 10 above
12 Evaluation of the questionnaires
NOTE if severe sideadverse effects are noted the test compound should be stopped immediately If mildmoderate sideadverse effects are noted the test component should be gradually stopped for 008 mgkg BWtday every 3 days
A Active Full-spectrum medical cannabis with ratio of CBDTHC 101 HemPhar
B Placebo both of the same producer
Study Steps
1 Informed consent should be signed by parentscaregivers
2 Weight of the participant should be determined and an IV line inserted The following lab tests should be performed CBC and differential counts blood electrolytes magnesium calcium phosphorus urea creatinine liver enzymes AST ALT gGT
3 ECG performed and analyzed
4 A trained physiotherapist will perform the following motor assessments spasticity level according to modified Ashworth scale Bohannon functionactivity assessment with the use of Gross Motor Function Measure scale GMFM-88 and assessment of muscle power with dynamometer
5 Randomization of patients into one of the two arms of the study
6 Active substance or placebo are introduced thereafter as an oral oily solution for oral application in a starting dose of 008 mgkg body weight BWtday divided in 2 doses the dose is according to the THC content The dose is gradually increased every 3 days for 008 mg THC kg BWtday until the maximum dose of 1 mg THCkg BWtday is reached or else until adverse effects are noted It is expected that the average dose will be 033 mgkg BWt per day
7 The parentscaregivers are given questionnairesscales and also given oral instructions on how to fulfil them Edmonton scale Borg scale and Global Impression of Change - GIC and the paper to take down notes on possible sideadverse effects while taking the preparation either active substance or placebo
8 After 6 weeks of taking the substance or at the premature end of the study again the lab tests will be performed as well as the motor assessment by the physiotherapist as above at inclusion
9 In patients who have been receiving placebo for the first 6 weeks the active substance is given for the next 6 weeks as described above under 6 The patients who have been receiving the active substance for the first 6 weeks will continue to do so for the next 6 weeks
10 Additional blood samples are taken at 6 weeks in both groups for analysis of levels of cannabidiol CBD as well as delta-9-tetrahydrocannbinol THC - around 4 ml of blood for determination of both levels at times after ingestion 0 1 2 4 8 and 24 hours
11 At the end of the study after 12 weeks again repeat
1 CBC and differential counts blood electrolytes magnesium calcium phosphorus urea creatinine liver enzymes AST ALT gGT
2 ECG
3 Motor assessments by a physiotherapist AshworthBohannon GMFM 88 dynamometer
4 Pharmacokinetics 4 ml of blood for determination of phamacokinetics after ingestion of the last dose as in point 10 above
12 Evaluation of the questionnaires
NOTE if severe sideadverse effects are noted the test compound should be stopped immediately If mildmoderate sideadverse effects are noted the test component should be gradually stopped for 008 mgkg BWtday every 3 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None